Lancet protective cap

ABSTRACT

A unique technique for maintaining the sterility and integrity of a lancet tip. One or more lancet tips are sandwiched between a first web and a second web of material to protect the sterility of the lancet tips. The first and second webs are heat fused together to form a structure that covers and encapsulates the lancet tips to protect the integrity of the lancet tips. The structure is cut to form individual protective caps to detachably cover each of the lancet tips.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.12/355,976, filed Jan. 19, 2009, which is a divisional of U.S.application Ser. No. 11/052,610, filed Feb. 7, 2005, now U.S. Pat. No.7,479,118, which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention generally relates to a unique technique formaintaining sterility and integrity of a lancet tip. More specifically,but not exclusively, the present invention concerns a manufacturingtechnique for quickly and easily producing a plurality of protectivecaps. Moreover, a plurality of lancet tips with protective caps can bestored in a cartridge or cassette.

Body fluid sampling devices have been developed to draw body fluid, suchas blood or interstitial fluid, from a person and analyze the drawnfluid for any number of characteristics, such as blood glucose levelsfor diabetics. To monitor a patient's condition, a medical practitioneror the individual first creates an incision in the skin by lancing thesubject's skin with a lancet. To avoid infection of the incision siteand/or contamination of the fluid collected, the lancet is sterilizedand packaged in a sterile manner prior to use. One form of packaging thelancet in a sterile environment is to place an entire lancet between twowalls of a layered material and heat seal a portion of the layeredmaterial around the entire lancet. The inner layers of the walls areusually formed from a protective sterilized padding and the outer layersof the walls are usually formed of a foil material. Between the innerwalls and the outer walls is an intermediate layer formed of adhesive.Heat and pressure of a heat-sealing die or other mechanism are appliedto the layered material around the perimeter of the entire lancet toform a heat seal line. As the heat and pressure are applied to thelayered material, the adhesive in the intermediate layer seeps throughthe inner and outer walls along the heat seal line to secure the wallstogether. To use the lancet, a user must peel apart the two walls alongthe heat seal line to expose the lancet. One issue often associated withsuch packaging is that the user must separate the walls while at thesame time maintain the lancet in the sterile package until the lancet isready to be used. Another difficulty that can be associated with suchpackaging is an excess amount of adhesive may seep through the inner andouter walls making it more difficult for a user to separate the walls.

Another form of packaging the lancet in a sterile environment involvescovering the tip of the lancet with a protective cap. One form ofapplying a protective cap onto the tip of the lancet is by injectionmolding. A material, usually plastic, is heated until it can flow andthen the material is injected into a mold that contains a lancet. Themold is shaped to form a protective cap to cover the lancet. Thematerial usually remains in the mold until it has cooled and solidified.The protective cap and lancet are removed from the mold.

A potential drawback for either sealing an entire lancet between twowalls of material or injection molding is a long cycle time in which toseal the lancet or form the cap. An example cycle time to seal an entirelancet between two walls of a material would include placing the entirelancet between two walls of a layered material and heat sealing aportion of the layered material around the entire lancet. An examplecycle time for injection molding would include heating the material,injecting the heated material into a mold, cooling the material in themold to form a protective cap, and removing the cap and lancet from themold. Another potential difficulty with sealing an entire lancet betweentwo walls of material or injection molding is that both forms tend to bemore costly to manufacture to protect the sterility of the lancet whencompared to other forms of maintaining the sterility of the lancet.Another obstacle often associated with a lancet is the safe disposal ofthe lancet upon use of the lancet. For example, the user or medicalpractitioner using the lancet would not want to accidentally prickanother person or themselves with a contaminated lancet therebypotentially exposing this person or themselves to disease. Frequently,the two walls of the sealed packaged lancet are separated to expose thelancet however; the two walls usually cannot be resealed together by themedical practitioner or the patient for safe disposal of a used lancet.Similarly, the replacement of the injection molded cap onto the lancettip may be difficult for persons with limited hand dexterity.

Maintaining the sterility of the lancet while at the same time providingfor ease in removal of the protective cap can be difficult, especiallywhen the test is self-administered.

Usually, the subject is either elderly or otherwise has some infirmitythat reduces their hand dexterity, which in turn makes removal of thecap difficult. One solution has been to weaken the connection betweenthe cap and the lancet, but by weakening this connection, the protectivecaps are more prone to be dislodged during shipping.

Thus, there remains the need for further improvement in this field.

SUMMARY

One aspect of the present invention concerns a method for covering alancing tip. At least the lancing tip is sandwiched between a first webof material resistant to melting at a specific temperature and a secondweb of material meltable at the specific temperature. The method alsoincludes melting the second web by heating both the first web and thesecond web to the specific temperature in order to encapsulate at leastthe lancing tip in a sterile enclosure. Further, during the melting thefirst web remains in an unmelted state to form a ribbon that protectsthe integrity of the lancing tip.

Another aspect concerns a device for maintaining sterility andprotecting integrity of a lancet tip. The device includes a lancet witha lancet tip for forming an incision in skin. Further, a first web of amulti-layered material contacts the lancet tip. A second web of themulti-layered material contacts the first web and sandwiches the lancettip between the first web and the second web to protect the sterility ofthe lancet tip. A structure is formed by heat fusing together the firstweb and the second web to protect the integrity of the lancet tip.Further, the structure is cut to form a protective cap that covers thelancet tip.

Further forms, objects, features, aspects, benefits, advantages, andembodiments of the present invention will become apparent from adetailed description and drawings provided herewith.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of a protective cap covering a lancet accordingto one embodiment of the present invention.

FIG. 2 is a perspective view of a plurality of lancets sandwichedbetween two webs according to the embodiment shown in FIG. 1.

FIG. 3 is a partial cross sectional view of the FIG. 2 webs as takenalong line 3-3 in FIG. 2.

FIG. 4 is a perspective view of a plurality of lancets on top of a webduring one stage of a manufacturing process.

FIG. 5 is a front view of a plurality of protective caps covering aplurality of lancet tips of lancets, each cap has a rectangular shapewith a tapered end having edges concave in shape.

FIG. 6 is a front view of a plurality of protective caps covering aplurality of lancet tips of lancets, each cap has a rectangular shapewith a tapered end having edges convex in shape.

FIG. 7 is a front view of a plurality of protective caps covering aplurality of lancet tips of integrated lancing test strips, each cap hasa rectangular shape with a tapered end having edges convex in shape.

FIG. 8 is a front view of a plurality of protective caps covering aplurality of lancet tips of lancets, each cap has a rectangular shapewith a tapered end having edges triangular in shape.

FIG. 9 is a front view of a plurality of protective caps covering aplurality of lancet tips of integrated lancing test strips, each cap hasa rectangular shape with a tapered end having edges triangular in shape.

FIG. 10 is a front cross-sectional view of a plurality of protectivecaps covering a plurality of lancet tips of lancets in a cartridge orcontainer.

DESCRIPTION OF THE SELECTED EMBODIMENTS

For the purpose of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended. Any alterations and further modificationsin the described embodiments, and any further applications of theprinciples of the invention as described herein are contemplated aswould normally occur to one skilled in the art to which the inventionrelates. One embodiment of the invention is shown in great detail,although it will be apparent to those skilled in the relevant art thatsome features that are not relevant to the present invention may not beshown for the sake of clarity.

The present invention generally concerns a protective cap that protectsthe integrity and sterility of a lancet tip for a lancet and/or anintegrated lancing test strip. It is envisioned that other devices maybe protected with the protective cap. One technique that quicklymanufactures the protective cap is to sandwich a lancet tip between twowebs of a multi-layer material to protect the sterility of the lancettip, heat seal the webs together to form a structure to protect theintegrity of the lancet tips, and cut the structure to form theprotective cap that covers the lancet tip. In another technique, aplurality of lancet tips are sandwiched between the two webs of themulti-layer material and a plurality of protective caps are formed fromthe structure. The layers of material for the webs are chosen based onthe application and desired properties or characteristics of the layersto protect the integrity and sterility of the lancet tip. The layers ofmaterial in contact with a lancet tip have a low melting point thatenables the layers to melt quickly and encapsulate the lancet tip asheat energy is applied to the web. The sterility of the lancet tip isprotected with encapsulation of the lancet tip. Further, a high meltingpoint for the layers of webs that form the exterior of the cap will notmelt as heat energy is applied to the multi-layered material. Theseexterior layers of web perform like a shell or mold as heat energy isapplied to the webs during the manufacturing process. Since theseexterior layers do not melt, heat energy can be applied to the exteriorlayers and the inner layers thus melting the inner layers andencapsulating the lancet tip. Strong cohesive layers of the webspositioned to form exterior surfaces of the cap also provide a rigidprotective outer layer or shell to protect the integrity of the lancettip.

Selected features from different embodiments of the present inventionwill be described with reference to a bare lancet or an integratedlancing test strip of the type illustrated in the drawings, but itshould nevertheless be appreciated that these features can beincorporated into other types of designs. As a non-limiting example,although the illustrated integrated lancing test strips have a lancetthat is fixed relative to the rest of the test strip, it should beappreciated that the lancet or other portions of the test strip can bemoveable relative to the rest of the test strip. It is envisioned thatmultiple lancets with protective caps or multiple integrated lancingtest strips with protective caps can be stored or joined together in acontainer to form a magazine or cassette.

A protective cap 20 according to one embodiment of the presentinvention, will now be described with reference to FIGS. 1, 2, and 3.The protective cap 20 includes a first web 22 and a second web 24. Alancet 26 is sandwiched between the first web 22 and the second web 24.As illustrated in FIG. 3, the first web 22 and the second web 24 aremade of a multi-layer material 28. In the embodiment shown in FIG. 3,the multi-layer material 28 is formed from a first layer 30 and a secondlayer 32. In other embodiments, the multi-layer material 28 may haveadditional layers other than first layer 30 and second layer 32 or mayhave only a single layer. In yet another embodiment, a portion of thefirst web 22 and/or the second web 24 melts at a specific temperature toencapsulate at least a lancet tip of lancet 26. In this embodiment,another portion of the first web 22 and/or the second web 24 does notmelt at the same specific temperature however this portion forms a rigidouter layer of the protective cap 20 to protect the integrity of thelancet tip. As a non-limiting example, the first web 22 and the secondweb 24 can be made of polystyrene and polyethylene.

In the illustrated embodiment, lancet 26 has a substantially flat shape.Lancet 26 with a flat shape is manufactured easily and quickly, andmultiple lancets 26 having flat shapes can be easily stacked or storedin a cassette or magazine. As should be appreciated, the lancet 26 canbe various geometric shapes. For example, lancet 26 can be rounded.Lancet 26 can be made from various materials, such as metal, plastic,ceramic, or a combination of metals such as metal and plastic to name afew materials.

As shown in FIG. 4, the lancet 26 has a lancet tip 34. The lancet tip 34is substantially triangular in shape, however it should be appreciatedthat the lancet tip 34 can be various geometric shapes. The lancet tip34 is configured to cut an incision into skin or other types of tissues.

As shown in FIG. 2, the protective cap 20 is formed from the first web22 and the second web 24. The first web 22 and the second web 24 areshown as rectangular pieces of multi-layer material 28 however in otherembodiments the first web 22 and the second web 24 may be shapeddifferently. It should be appreciated that first web 22 and/or secondweb 24 shaped as rectangular pieces tend to roll onto a spindleuniformly as compared to other shapes. It is envisioned that a spindleof first web 22 and a spindle of second web 24 may be used to form theprotective cap 20 to increase the speed of manufacturing the protectivecap 20 as discussed below. For illustrative purposes, in FIG. 2 thefirst web 22 has a width greater than a width of the second web 24. Inother forms, the width of the first web 22 may be substantially equal toor less than the width of the second web 24. In addition, forillustrative purposes, the length of the first web 22 is greater thanthe length of the second web 24 in FIG. 2. As should be appreciated inother forms the length of the first web 22 may be substantially equal toor less than the length of the second web 24.

Multi-layer material 28, as shown in FIG. 3, includes first layer 30 andsecond layer 32. In one embodiment, multi-layer material 28 can beformed by co-extruding first layer 30 and second layer 32 from a deviceonto a surface configured to receive first layer 30 and second layer 32.It is envisioned that the surface is shaped to receive first layer 30and/or second layer 32 to form multi-layer material 28, howevermulti-layer material 28 can be removed from the surface.

In another form, first layer 30 may be extruded from a device onto asurface and second layer 32 may be extruded onto first layer 30 to formthe multi-layer material 28. It should be appreciated that multi-layermaterial 28 can be formed by other techniques. It is envisioned thatmulti-layer material 28 can be bent or rolled onto a spindle for storageand/or use during the manufacture of the protective cap 20.

The materials for first layer 30 and second layer 32 are chosen based ondesired characteristics or properties of the protective cap 20. Onedesirable characteristic is a high melting point of the first layer 30.First layer 30 of first web 22 and first layer 30 of second web 24 forman exterior surface of the protective cap 20 as shown in FIGS. 1, 2, and3. A high melting point for first layer 30 prevents first layer 30 frommelting as heat energy is applied to web 22 and/or web 24 to heat thewebs to a specific temperature. As heat energy is applied to web 22and/or web 24, first layer 30 performs similar to a shell or mold forthe second layer 32 during the manufacturing process. Another desiredcharacteristic is a low melting point of second layer 32. For example,second layer 32 of first web 22 and second layer 32 of second web 24contact lancet tip 34 in the embodiment shown in FIGS. 1, 2, and 3. Alow melting point for second layer 32 enables second layer 32 to meltquickly and encapsulate lancet tip 34 with a small amount of heat energyapplied to it to heat second layer 32 to the specific temperature. Heatenergy can be applied to first layer 30 and second layer 32 in contactwith the lancet tip 34 thus melting second layer 32 and encapsulatingthe lancet tip 34. Encapsulating the lancet tip 34 with the second layer32 protects the sterility of the lancet tip 34. A low melting pointdecreases the amount of time required to heat the second layer 32.Another desirable property is the cohesiveness of first layer 30 and/orsecond layer 32. In the embodiment shown in FIGS. 1, 2, and 3, firstlayer 30 of first web 22 and first layer 30 of second web 24 each forman exterior surface of the protective cap 20. A strong cohesive firstlayer 30 of first web 22 and first layer 30 of second web 24 provide arigid protective outer layer or shell to protect the integrity of lancettip 34. An additional desirable property or characteristic is theadhesiveness of first layer 30 to second layer 32. The adhesiveness offirst layer 30 to second layer 32 enables the layers to stick togetherto form the multi-layer material 28. It should be appreciated that anintermediate layer of adhesive can be placed between the first layer 30and second layer 32 to hold these layers together. Other characteristicsas desired can be chosen to determine the type of material to be usedfor the first layer 30 and/or the second layer 32.

In one form wherein heat energy from a laser is applied to web 24, thefirst layer 30 and/or second layer 32 of web 22 may be colored a darkcolor to absorb heat energy from the laser. In this form, energy from alaser is applied to the first layer 30 of web 24. The first layer 30 andthe second layer 32 of web 24 are colorless to enable the darkly coloredweb 22 to absorb heat energy from the laser. As should be appreciated,other forms of applying heat energy to web 22 and/or web 24 arediscussed below. It is envisioned that first layer 30 and/or secondlayer 32 of web 22 and web 24 may be any color the user desires if heatenergy in forms other than a laser are applied to web 24.

In one form, the first layer 30 and/or the second layer 32 may have asmooth surface for receiving the lancet tip 34 and/or a user or device,respectively. In another form, second layer 32 has ridges or a textureon its surface that contacts the lancet tip 34. Further, when heatenergy is applied to the web 22 and/or web 24, the ridges enable thesecond layer 32 to melt quickly and encapsulate the lancet tip 34.

First layer 30 and second layer 32 can be made from various materials.In one embodiment, first layer 30 is made of polystyrene and secondlayer 32 is made of polyethylene. By non-limiting example, first layer30 is approximately 0.3 millimeters and second layer 32 is approximately0.1 millimeters. As should be appreciated in this embodiment, firstlayer 30 of first web 22 is positioned away from lancet tip 34 and formsa rigid outer layer of the protective cap 20. As should also beappreciated in this embodiment, heating the second layer 32 positionedadjacent the lancet tip 34 encapsulates the lancet tip 34 within thesecond layer 32. In other embodiments, first layer 30 may be formed bymaterials such as metal, plastic, or polyester, or composites such asmetal and plastic, or any other materials in which the first layer 30 isa heat resistant material that also forms a protective outer layer ofthe cap 20. Second layer 32 may be formed by materials such asthermoplastic, polymer, plastic, or any other materials that can melt toencapsulate lancet tip 34 and can be removed from lancet tip 34 for useof the lancet 26.

Lancet tip 34 is sandwiched between first web 22 and second web 24. Asshown in FIG. 2, multiple lancets 26 can be sandwiched between first web22 and second web 24. In this form, first web 22, lancets 26, and secondweb 24 are assembled in a layer like fashion such that multipleprotective caps 20 can be easily assembled and manufactured in acontinuous fashion. In one manufacturing process, as shown in FIG. 4, acontinuous web 22 is positioned such that multiple lancet tips 34 areplaced in a side-by-side fashion on top of web 22. Next, as shown inFIG. 2, a continuous web 24 is placed over the lancet tips 34 therebysandwiching the lancet tips 34 between the first web 22 and the secondweb 24. As discussed below, heat energy is applied to the web 22 and/orthe web 24. It is envisioned that various techniques may be used tosandwich the lancet tips 34 between the first web 22 and the second web24 and increase the speed of manufacturing the protective caps 20. Byway of non-limiting example, first web 22 can be rolled onto a firstspindle and second web 24 can be rolled onto a second spindle toincrease the speed of manufacturing. Further, as the first web 22 andthe second web 24 are unrolled, a plurality of lancet tips 34 arepositioned in a side-by-side fashion between the first web 22 and thesecond web 24. In this form, a thermoplate can apply heat energy to thesecond web 24 as web 24 is unrolled from the spindle. The heated web 24is placed on top of the first web 22 wherein second layer 32 of web 22and second layer 32 of web 24 melt to encapsulate the lancet tip 34.

First web 22 and second web 24 are heat fused together to create astructure or one-piece ribbon 36 as shown in FIG. 5. Heat energy isapplied to first web 22 and/or second web 24 to bond the webs togetherto form the structure 36 to protect the integrity of the lancet tip 34.The lancet tip 34 remains sandwiched between the webs while heat energyis applied to first web 22 and/or second web 24. The lancet tip 34 isembedded in the structure 36 as the second layer 32 of first web 22and/or the second layer 32 of second web 24 melts and encapsulates thelancet tip 34. One source of heat energy is the application ofelectromagnetic radiation by a laser to the first web 22 and/or thesecond web 24. For the application of heat energy by a laser to secondweb 24, it is beneficial to have a darkly colored first web 22 and acolorless second web 24 as the laser emits radiation toward thecolorless second web 24. The darkly colored first web 22 absorbs moreheat and energy from the laser thus heating and melting the second layer32 of the first web 22 and the second layer 32 of the second web 24. Inone embodiment, a laser with electromagnetic radiation produced with anapproximate wavelength of 790 to 830 nanometers may be used as a sourceof heat energy. Another example of heat energy can be infrared radiationapplied to first web 22 and/or second web 24 to form structure 36.Thermal plates or thermal rollers may also be applied to the first web22 and/or the second web 24 to form structure 36. One range of heat forthe thermal plates or thermal rollers may be approximately 95° to 130°Celsius. In one form, the structure 36 is cooled to a desiredtemperature to form the protective cap 20 to cover the lancet tip 34.

One-piece structure 36 can be cut into a desired shape to form apull-off tab or protective cap 20. A few shapes for the cap 20 arerectangular, circular, or triangular. The shape of cap 20 can varywhether the cap 20 covers a lancet 26 or an integrated lancing teststrip 38. Further, the shape of cap 20 can vary whether it is for usewith an individual use device or with a cartridge or cassette 50 thatstores multiple lancets 26 or integrated lancing test strips 38 asillustrated in FIG. 10 and described below. The cartridge 50 can beconfigured to store multiple lancets 26 or integrated lancing teststrips 38 with caps 20. In another form, one-piece structure 36 is notcut but remains a continuous strip. In this embodiment, the structure 36forms a continuous strip that can be received in a cartridge ormagazine. Various techniques may be used to cut the structure 36. Oneform of cutting the structure 36 to form the protective cap 20 is diecutting. Another technique used to cut structure 36 is to punchstructure 36 with a machine that forms the shape of each protective cap20. Yet another technique used to cut structure 36 to shape theprotective cap 20 is a rotary shear.

The protective cap 20 protects the integrity and sterility of the lancettip 34. As should be appreciated, the protective cap 20 can also protectthe integrity and sterility of an integrated lancing test strip 38 asshown in FIGS. 8 and 9. As should also be appreciated, the integratedlancing test strip 38 includes a lancet and a test strip or othertesting means to analyze bodily fluid. The test strip can analyze fluidthrough electrochemical means, such as electrodes and a reagent,optical, and/or magnetic analysis to name a few means. In oneembodiment, the lancet is sterilized before attaching the lancet to thetest strip to form the integrated lancing test strip 38. In anotherembodiment, the lancet is attached to the test strip to form theintegrated lancing test strip 38 and then the lancet is sterilized. Inthis embodiment, the test strip is calibrated.

To use the lancet 26, the cap 20 must be removed from the lancet tip 34.To remove the cap 20 and expose the lancet tip 34 for an individual usedevice, a user pulls the cap 20 in a direction opposite to the lancet26. The cap 20 functions as a pull-off tab in which the user removes thecap 20 by pulling the cap 20 in a direction away from the lancet 26. Toaid a user in removing the cap 20, an indicator or symbol 40 may beplaced on the cap 20 as shown in FIG. 5. As shown, the symbol 40 aidsthe user by giving instructions or showing the direction in which topull the cap 20 to remove it from the lancet tip 34. In other forms, thesymbol 40 may be a manufacturer's logo, trademark, or any other words orfigures. To manually remove the cap 20, a user grabs the cap 20 in areasmarked by arrows 41 as shown in FIG. 1. The user begins to pull the cap20 in a direction away from the lancet 26 as indicated by the symbol 40in FIG. 5. As the user exerts a force on the cap 20, the molded cap 20shears away from the lancet tip 34. As the user continues to pull thecap 20 away from the lancet 26, the cap 20 eventually breaks its sealwith the lancet tip 34, and the cap 20 is fully removed from the lancet26 to expose the lancet tip 34.

In some forms, the cap 20 and the lancet tip 34 are stored in a cassetteor cartridge, and to remove the cap 20 from the lancet tip 34 a toolwithin the integrated testing device will engage the cap 20 and removeit to expose the lancet tip 34. It should be appreciated there arevarious techniques for automatically removing the cap 20 from the lancet26 or the integrated lancing test strip 38 housed in a cassette. Thesetechniques are known in the art and not important to appreciate thepresent invention, therefore these techniques will not be discussed indetail below.

As illustrated in FIGS. 5, 6, 7, 8, and 9 and described below, thestructure 36 may be cut to form multiple protective caps 20 with variousshapes. As should be appreciated, the shaped protective caps 20illustrated in FIGS. 5, 6, and 7 are configured for use with anindividual use testing device in which the user will manually remove thecap 20 from the lancet tip 34. As should also be appreciated, the shapedprotective caps 20 illustrated in FIGS. 8 and 9 are configured for usewith an integrated testing device that stores a plurality of protectivecaps 20 and lancets 26 (or integrated lancing test strips 38) in acassette.

As illustrated in FIG. 5, the structure 36 may be cut to form anergonomically shaped protective cap 20. The protective cap 20 has atapered end 42. Protective cap 20 is substantially rectangular in shape.As should be appreciated, tapered end 42 can be shaped to aid the userin grasping and removing the protective cap 20. Tapered end 42 has edges44 that are semicircular in shape. In addition, edges 44 are concave inshape.

In accordance with FIG. 6, protective cap 20 a, includes tapered end 42a. As should be appreciated, protective cap 20 a is similar to cap 20.Tapered end 42 a includes edges 44 a that are circular in shape however;the edges 44 a form a convex shape.

Referring to FIG. 7, protective cap 20 b has a tapered end 42 b withedges 44 b. Protective cap 20 b is similar to cap 20 a.

With reference to FIG. 8, protective cap 20 c is substantiallyrectangular in shape with a tapered end 42 c having a triangular shapededge 44 c in the form of an isosceles triangle. In other forms, theshaped edge 44 c can be angled differently. For example, the shaped edge44 c can form a right triangle, or a scalene triangle, to name a fewshapes. Protective cap 20 c also has indentations 46 c. Indentations 46c are semicircular in shape. In other forms, the indentations 46 c canbe shaped differently. As should be appreciated, the shaped edge 44 cand/or the indentations 46 c assist a device, mechanical or electrical,in grasping and removing the protective cap 20 c.

A protective cap 20 d according to another form is illustrated in FIG.9. As shown, the protective cap 20 d has a tapered end 42 d. Tapered end42 d includes triangular shaped edges 44 d in the form of an isoscelestriangle. As should be appreciated, protective cap 20 d is similar toprotective cap 20 c.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges and modifications that come within the spirit of the inventionare desired to be protected.

1. A device, comprising: a lancet having a lancet tip configured to forman incision in skin; a first web of a multi-layered material, whereinthe multi-layered material has a rigid first layer and a heat-sensitivesecond layer; a second web of the multi-layered material, the secondlayer of the second web contacting the second layer of the first web andsandwiching the lancet tip between the first web and the second web toprotect sterility of the lancet tip; wherein the second layer of thefirst web and the second layer of the second web are melted together toform a one-piece removable tab to encapsulate the lancet tip; andwherein the first layer of the first web and the first layer of thesecond web form a protective outer surface of the one-piece removabletab.
 2. The device of claim 1, wherein: the first layer includespolystyrene; and the second layer includes polyethylene.
 3. The deviceof claim 1, further comprising: a plurality of the lancet tipssandwiched between the first web and the second web.
 4. The device ofclaim 1, further comprising: a plurality of the lancet tips sandwichedbetween the first web and the second web; a plurality of the one-pieceremovable tabs configured to encapsulate said plurality of the lancettips; and a cartridge for storing the plurality of the one-pieceremovable tabs and the plurality of the lancet tips.
 5. The device ofclaim 1, wherein the one-piece removable tab is cut to form a protectivecap to cover the lancet tip.
 6. The device of claim 1, wherein the firstlayer is heat-resistant.
 7. The device of claim 1, further comprising: atest strip attached to the lancet and adapted to analyze bodily fluidfrom the incision.
 8. The device of claim 1, further comprising: anadhesive layer positioned between the rigid first layer and theheat-sensitive second layer to hold the first and second layerstogether.
 9. The device of claim 1, wherein the first layers of thefirst and second webs are made of a transparent material and the secondlayers of the first and second webs are made of an opaque material. 10.A device, comprising: a lancet having a lancet tip configured to form anincision in skin; a first web of a multi-layered material, wherein themulti-layered material has a heat-resistant first layer and aheat-sensitive second layer, wherein either the first layer or thesecond layer is colored a dark color; a second web of the multi-layeredmaterial, wherein the heat-resistant first layer and the heat-sensitivesecond layer are colorless, the second layer of the second webcontacting the second layer of the first web and sandwiching the lancettip between the first web and the second web to protect sterility of thelancet tip; and wherein the second layer of the first web and the secondlayer of the second web are melted together by energy from a laser toform a one-piece removable tab to encapsulate the lancet tip.
 11. Thedevice of claim 10, further comprising: a test strip attached to thelancet and adapted to analyze bodily fluid from the incision.